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| ID | Type | Description | Link |
|---|---|---|---|
| D638-1118 | Other Identifier | ResMed |
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The goal of this multi-site, prospective, randomized, double arm study without blinding is to test the usability of the Whitsundays mask system at home by patients with Obstructive Sleep Apnea. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A provided with 1 Whitsundays Nasal mask without a spare mask cushion | Experimental | • Provided with 1 Whitsundays Nasal mask without a spare mask cushion (To be provided as requested) |
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| Group B provided with 1 Whitsundays Nasal mask with 2 spare mask cushions | Experimental | • Provided with 1 Whitsundays Nasal mask with 2 spare mask cushions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion | Device | Group A will be provided with 1 Whitsundays Nasal mask without a spare mask cushion (replacement cushions will only be provided when requested) |
| Measure | Description | Time Frame |
|---|---|---|
| 11 point Likert Scale Questionnaire | • Subjective scores will be collected from subjects on each attribute being assessed (e.g. visual appeal, ease of use, ease of cleaning, seal, comfort, overall performance etc.). Scores will be collected using an 11-point Likert Scale Questionnaire. Minimum value will be zero. Maximum value will be 10. A higher score indicates better outcomes. A score of 10 is considered very favorable, and a score of 0 is very unfavorable. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 11 point Likert Scale Questionnaire | • Subject's subjective impression and comments comparing the prototype mask (Whitsundays Nasal) to the subject's current mask with regards to ease of use, visual appearance, seal, comfort, facial markings, noise and overall performance. • Scores will be collected using an 11-point Likert Scale Questionnaire. Minimum value will be zero. Maximum value will be 10. A higher score indicates better outcomes. A score of 10 is considered very favorable, and a score of 0 is very unfavorable. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Hevener, RPSGT | Sleep Data | Principal Investigator |
| Matthew Uhles, MS | Clayton Sleep Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Data | San Diego | California | 92123 | United States | ||
| Clayton Sleep Institute |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushions | Device | Group B will be provided with 1 Whitsundays Nasal mask with 2 spare mask cushions |
|
| 90 days |
| Apnea Hypopnea Index (AHI) | • The AHI recorded by the subject's PAP device while using their own mask will be compared to the AHI recorded by the subject's PAP device while using the Whitsundays mask. The AHI will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits. | 90 days |
| Compliance | • The subject's average daily hours of use of PAP therapy recorded by the subject's PAP device while using their own mask will be compared to the average daily hours of use recorded by the subject's PAP device while using the Whitsundays mask. The average daily hours of use will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits. | 90 days |
| Leak | The median air leak (L/minute) recorded by the subject's PAP device while using their own mask will be compared to the median air leak (L/minute) recorded by the subject's PAP device while using the Whitsundays mask. The median air leak will be obtained from the ResMed AirView Compliance Reports downloaded during the study visits. | 90 days |
| Pressure Differences | The median air pressure (cmH2O) used during PAP therapy recorded by the subject's PAP device while using their own mask will be compared to the median air pressure (cmH2O) recorded by the subject's PAP device while using the Whitsundays mask. The median air pressure levels will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits. | 90 days |
| Frequency of Cushion Replacement | • Subject's frequency of cushion replacement will be recorded using the Mask Cushion Change Form to be provided to Group B participants on Day 14 and every 2 weeks for the duration of the study. The Mask Cushion Change form will be provided to Group A participants who request a cushion change. | 90 days |
| Reason for Cushion Replacement | • Subject's reason for cushion replacement will be recorded using the Mask Cushion Change Form to be provided to Group B participants on Day 14 and every 2 weeks for the duration of the study. The Mask Cushion Change form will be provided to Group A participants who request a cushion change. | 90 days |
| Deterioration of Mask | • Photos of the subject's prototype mask system taken at 2-week intervals to observe any visual deterioration such as cracking, crazing, tears, dirt or stain build up | 90 days |
| St Louis |
| Missouri |
| 63123 |
| United States |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |